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Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection

NCT06544551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2024-08-09

No results posted yet for this study

Summary

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.

Conditions

  • Chronic Hepatitis B Virus Infection

Interventions

DRUG

Peginterferon Alfacon-2

Peginterferon Alfacon-2 injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

DRUG

Peginterferon Alfacon-2 placebo

Peginterferon Alfacon-2 placebo injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

Sponsors & Collaborators

  • Beijing Kawin Technology Share-Holding Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2023-11-30
Completion
2023-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544551 on ClinicalTrials.gov